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CompletedNCT01893528Updated Nov 10, 2014

Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

A Phase 1 interventional study of REGN2009 and placebo in Healthy Volunteers, sponsored by Regeneron Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-10.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 410 studies on the registry; 93 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy men and women ages 18 to 65 years inclusive
  2. Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breast-feeding women
  2. Any clinically significant abnormalities observed during screening (day -21 to day -2)
  3. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
  4. History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
  5. Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
  6. Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
  7. History of a hypersensitivity reaction to doxycycline or similar compound
  8. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
  9. Previous adverse experience to any biological investigational or therapeutic agent
  10. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    REGN2009 dose level 1

    Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

    Drug: REGN2009 · Other: placebo

  • Experimental
    REGN2009 dose level 2

    Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

    Drug: REGN2009 · Other: placebo

  • Experimental
    REGN2009 dose level 3

    Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

    Drug: REGN2009 · Other: placebo

Interventions

  • DrugREGN2009
  • Otherplacebo
06

What researchers measure

Primary outcomes

  1. Number of TEAEs

    The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.

    Time frame: day 1 to day 106/ visit 15

07

Study locations

2 sites
  • Baltimore, Maryland, United States
  • Cincinnati, Ohio, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2013
First posted
Jul 9, 2013
Start
Jun 2013
Primary completionActual
Sep 2014
CompletionActual
Sep 2014
Last update
Nov 10, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01893528
Responsible party
Sponsor
First posted
Jul 9, 2013
Start date
Jun 2013
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Nov 10, 2014

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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